Unique Automated HPLC Method Development and Validation Software Speeds up Sample Throughput for Pharma and Biotech Applications
Varian, Inc. today announced the availability of the new Fusion AE(TM) software companion plug-in application for its Galaxie(TM) Chromatography Data System (CDS) to enable automated high performance liquid chromatography (HPLC) method development and validation. Fusion AE integrates seamlessly with Varian’s Galaxie CDS software, offering users the ability to optimize methods based on simultaneously entered multiple variables on a variety of HPLC equipment from multiple vendors.
For pharmaceutical, biotechnology, and other industrial labs required to meet the requirements of regulatory authorities, such as the Federal Drug Administration (FDA) or Environmental Protection Agency (EPA), Fusion AE simplifies and streamlines the process, speeding up sample throughput by providing rapid optimization and validation of methods on a continuous basis.
In pharmaceutical research and development (R&D) laboratories, scientists can use Fusion AE’s method development/optimization option to rapidly and automatically optimize methods based on simultaneously entered multiple variables, such as mobile phase composition, flow rate, column packing functionality, injection volume, temperature, and pH, among others. Competitive software packages are capable of studying only one or two variables simultaneously.
In addition, the new software’s phased approach to method validation lets scientists run quick checks to determine whether the method can be validated while in the development phase. Once optimized, the scientists then can run the full complement of required method validation experiments automatically. This results in bench-time savings as well as higher sample throughput. Fusion AE(TM) meets the FDA’s stringent 21 CFR Part 11 regulatory requirements, and all method validation experiment designs, analysis, and reporting conform to FDA and ICH guidances.
In the same companies, quality control (QC) labs can use Fusion AE’s automated method validation component to revalidate analytical methods transferred from R&D, saving time and eliminating errors. Fusion AE has demonstrated a 60% to 85% reduction in cycle time (including data analysis and report generation) compared to current manual execution of validation standard operating procedures (SOPs).
Fusion AE is the latest add-on to enhance the functionality of Varian’s Galaxie CDS. At last year’s Pittcon, Varian introduced the Galaxie(TM) DataBase, which gave customers an option for either structured file or relational data storage and archiving. Combined with Fusion AE and Galaxie DataBase, Galaxie CDS is a complete software solution for compliant, networked environments.
Orders are currently being taken for the new Fusion AE, with shipments beginning in May 2005.
Varian, Inc. supplies a broad range of scientific instruments and consumable supplies for health science applications. Since 1999, the company has maintained a balanced approach to enhancing and expanding its products for life science and industrial customers.
For further product information on the Galaxie CDS and Fusion AE, please visit: http://www.varianinc.com/products/chrom/cds/index.html .
Varian, Inc. is a major supplier of scientific instruments, vacuum technologies, and specialized contract electronics manufacturing services. These businesses serve a broad range of life science and industrial customers worldwide. The company manufactures in 15 locations in North America, Europe, and the Pacific Rim, and employs some 4,600 people. Varian, Inc. had fiscal year 2004 sales of $916 million. Additional information about Varian, Inc. is available at www.varianinc.co .
